COLUMBIA, Md.--(BUSINESS WIRE)--CELSION CORPORATION (AMEX: CLN) today announced that its application for a Special Protocol Assessment (SPA) for its Pivotal Phase III Primary Liver Cancer trial has been agreed to by the US Food and Drug Administration. With this agreement, Celsion will begin immediate implementation of the study which has been planned in detail during the course of FDA’s review. The study is designed to demonstrate the efficacy of Celsion’s proprietary chemotherapeutic, ThermoDox, in combination with radiofrequency ablation as a first line treatment of primary liver cancer, the fifth largest cancer globally with an incidence of over 650,000 cases annually. The study will incorporate about 40 clinical sites in North America, Italy, China, Taiwan, Hong Kong, and Korea, and is planned to enroll 600 patients and specifies the primary end point as Progression Free Survival.
